Fluid flow control valve and flow control devices and methods employing same

ABSTRACT

A fluid flow control valve includes a valve body with a fluid flow lumen therethrough and a valve member located within the fluid flow lumen. At least one of the valve body and valve member is resilient and respectively sized for movement between a normally closed position in which the valve member and a fluid lumen surface are in sufficient annular contact to block fluid flow through the fluid flow lumen and an open position in which at least one of the valve body and valve member flexes to a spaced apart position that allows fluid flow between them. Downstream fluid pressure may contact the valve body to enhance sealing. A fluid absorbent member may also be employed with the valve body. Flow control devices, such as medical fluid injection devices, and methods may employ this valve.

The present application generally relates to flow control valves andmore particularly to medical fluid transfer and/or injection devices formedical fluids that employ such valves.

BACKGROUND

Development efforts have continued in recent years in the development ofnew and/or improved devices for transferring, reconstituting and/orinjecting medical fluids, such as drugs, antibiotics, vaccines,biologics and other medicaments for therapeutic and/or diagnosticpurposes. One example of such a development may be found in PCTpublication WO2014/204894 A2 by Enable Injections LLC of Franklin, OhioUSA, which is incorporated by reference herein. That publicationdiscloses a medical fluid injection device and an associated system ordevice for fluid transferring, mixing, diluting and/or reconstituting amedical fluid for injection. The injection device employs an internalreservoir in the form of a resilient balloon or bladder that expands asit is filled with medical fluid from the transfer device. The injectiondevice may, after filling, be removed from the transfer device andplaced on the skin of a patient and activated. Upon activation, aninjection needle is advanced from the device into the skin of thepatient and the inherent pressure provided by the expanded resilientreservoir forces the medical fluid through the needle and into thepatient. This injection device and others that are functionally similarmay use flow control valves, such as check valves or one-way valves, tocontrol the flow of medical fluid.

While flow control valves are, in general, well known in a wide varietyof technical settings, and in a variety of configurations, therecontinues to be a need for new valve design and development, including,without limitation, valves particularly suited for use in medical fluidtransfer and/or injection devices such as found in the above identifiedPCT publication. One known form of valve employs a ball within aflexible tube to control flow therethrough. Examples of these may befound in U.S. Pat. Nos. 605,693; 2,314,767; and 6,923,785; U.S.published application no. 2006/0163506; Great Britain patent applicationGB 2,091,853(A); and European patent application EP 0800032(A1).

SUMMARY

The present subject matter is directed to a novel flow control valve andto injection devices and/or transfer, mixing or reconstitution devicesemploying such a valve and to methods of their use. The followingnon-limiting summary is to acquaint the reader generally with variouspotential aspects of the present subject matter, and is non-exclusivewith respect to the various possible aspects or combinations of aspectsfound in such device or method. Additional aspects of the presentsubject matter may be found in the detailed description below, in theaccompanying claims and/or in the accompanying figures.

In accordance with one aspect of the present subject matter, a fluidflow control valve includes a valve housing defining a valve cavity withan inlet and an outlet. A valve body having a fluid flow lumen and avalve member located within the fluid flow lumen are positioned in thevalve cavity and control flow between the inlet and outlet. The valvebody is resilient and the valve body and valve member are respectivelysized such that the valve member is cross-sectionally larger than thefluid flow lumen when the valve body and valve member are in asubstantially unstressed condition so as to result in annular contactbetween the valve member and valve body that substantially blocks fluidflow through the fluid flow lumen in the absence of fluid pressure fromthe inlet. The resiliency of the resilient valve body allows formovement between a normally closed position in which the valve memberand fluid lumen surface are in contact and block flow, and an openposition in response to fluid pressure from the inlet, in which thevalve body flexes to allow fluid flow between the valve body and valvemember. The valve body includes an exterior surface that is exposed, atleast in part, to pressure from fluid between the valve member andoutlet. This allows the pressure of the downstream fluid to pressagainst the valve body and help create sealing contact against the valvemember.

In accordance with another aspect of the present subject matter amedical fluid injection or transfer device may comprise a housing, areservoir within the housing for receiving medical fluid, an inlet portin the housing for receiving medical fluid from a source, and a fluidflow path in the housing communicating between the inlet port andreservoir. The fluid flow path includes a one-way valve that includes avalve body including a fluid flow lumen therethrough and a valve memberlocated within the fluid flow lumen. At least one of the valve body andvalve member is resilient and respectively sized for movement between anormally closed position in which the valve member and a fluid lumensurface are in sufficient annular contact to block fluid flow throughthe fluid flow lumen in the absence of fluid pressure from the inletport, and an open position in response to fluid pressure from the inletport in which at least one of the valve body and valve member flexes toa spaced apart position that allows fluid flow between them.

In accordance with another aspect of the present subject matter amedical fluid injection device comprises an injection device housing, aresilient expandable reservoir within the housing for receiving medicalfluid, an injection needle carried by the housing, an injection flowpath for communication between the injection needle and reservoir, aport in the housing for receiving medical fluid under pressure from asource, and an inlet fluid flow path in the housing communicatingbetween the inlet port and reservoir for introducing medical fluid intothe reservoir. The inlet fluid flow path includes a one-way valve forallowing fluid flow from the inlet port into the reservoir andpreventing fluid flow from the reservoir to the inlet port. The one-wayvalve includes a valve body including a substantially resilient sleeveportion through which inlet flow path extends, a valve inlet for fluidflow into one end of the inlet flow path and a valve outlet for fluidflow from the other end of the inlet flow path. A substantially rigidvalve member is located within the inlet flow path of the resilientsleeve portion between the valve inlet and valve outlet. The valvemember is sized such that it has a cross-sectional size larger than theinlet flow path in a substantially unbiased condition, such that thesleeve normally contacts the valve member and blocks fluid flow throughthe valve body from the reservoir to the inlet port. The sleeve isresiliently expandable under fluid pressure from the inlet port to allowfluid flow from the inlet port toward the reservoir.

In yet another aspect, a medical fluid flow control device comprises ahousing, a resilient expandable reservoir within the housing, an inletport in the housing for receiving medical fluid from a source and anoutlet port in the housing for flow of fluid from the housing and afluid flow path between the inlet port and the reservoir and between thereservoir and the outlet port. The fluid flow path between the inletport and reservoir includes a normally closed one-way valve for allowingfluid flow from the inlet port into the reservoir and preventing fluidflow from the reservoir to the inlet port. In this aspect, the valve mayhave two seals or sealing areas that help prevent flow from thereservoir to the inlet port. The one-way valve includes a valve body.The valve body includes a resilient hollow sleeve portion defining afluid flow lumen therein, a valve body inlet for fluid flow into one endof the fluid flow lumen from the inlet port and a valve body outlet forfluid flow from the other end of the fluid flow lumen into thereservoir. A substantially separate rigid valve member is located withinthe lumen of the resilient sleeve portion and is sized such that thevalve member is larger than the lumen of the resilient sleeve when thesleeve is in an unbiased condition, whereby the sleeve portion willnormally exert an annular inward force against an outer surface of thevalve member to provide an annular first seal between the valve memberand sleeve and block flow through the fluid flow lumen from thereservoir to the inlet port. The sleeve has an outer surface in fluidcommunication with the fluid flow path between the valve and reservoirand is resiliently expandable under sufficient fluid pressure from theinlet port to allow fluid flow between the valve body and valve memberand into the resilient reservoir. The valve body further defines anannular valve seat in the lumen between the valve member and valve bodyinlet, which valve seat is contacted by the valve member in the normallyclosed condition to provide an additional seal against fluid flow fromthe reservoir. The valve member is movable away from the valve seatunder fluid pressure from the inlet port to allow fluid flow through thefluid flow lumen between the valve seat and valve member.

These and other aspects of the present subject matter are set forth inthe following more detailed description and accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a transfer device and injection devicecombination or assembly within an outer package, which employs a flowcontrol valve in accordance with the present disclosure.

FIG. 2 is side view of the combination of FIG. 1 with the outer packageremoved and portions of the injection device and transfer device insectional view for better depiction of the structures.

FIG. 3 is an exploded perspective view of certain parts of the injectiondevice of FIG. 1.

FIG. 4 is a vertical cross-sectional view of the injection device ofFIG. 1 and a portion of the transfer device.

FIG. 5 is a horizontal cross-sectional view of the injection device ofFIG. 1.

FIG. 6A is a perspective view of one embodiment of a valve body andvalve member that may be employed in the injection and/or transferdevice exemplified in FIG. 1.

FIG. 6B is a perspective view of the embodiment of a valve body andvalve member shown in FIG. 6A, taken from a different viewing angle.

FIG. 7A is a side view of the valve body of FIG. 6A.

FIG. 7B is a bottom view of the valve body of FIG. 7A.

FIG. 7C is a cross-section view of the valve body of FIG. 7A, takenalong line 7C-7C.

FIGS. 8A and 8B are enlarged cross-sectional views of the of theinjection and transfer device combination of FIG. 2, showing the valvein closed position in FIG. 8A and in open position in FIG. 8B.

FIGS. 9 cross-sectional views similar to FIG. 8A with certain parts ofthe injection or transfer device removed, and diagrammatically showingthe fluid forces acting on the valve after the injection device isfilled and before administration to a patient.

DETAILED DESCRIPTION

As illustrated for purposes of explanation and not limitation, FIG. 1depicts, in perspective view, a combined medical fluid transfer andinjection device, generally at 10, in accordance with the presentsubject matter. The combination transfer and injection device 10includes a transfer device or assembly 12 and an injection device orassembly 14. This combination is intended for one-time use only and isillustrated in an exemplary outer container or package 16 for shipmentand/or storage.

The illustrated embodiment of the transfer device 12 allows the transfermedical fluid, which may be any injectable fluid such as for diagnosticor therapeutic purposes including, without limitation, drugs,antibiotics, chemotherapy or similar agents, biologics or othermedicament, from a fluid source such as a standard syringe to theinjection device 14. The transfer device includes a plastic tray 18 thathas syringe receiving station or recess 20 and an injection devicereceiving station or recess 22. The illustrated injection device recesshas a generally elongated and oval configuration that allows the user togrip and remove the injection device when needed. The particularinjection device 14 is illustrated substantially as disclosed in the PCTpublished application incorporated by reference above, except that itemploys a novel valve structure as described herein for controlling flowof fluid from the fluid source the injection device.

FIG. 2 is a side view of the transfer and injection device orcombination 10 with the package 16 and tray 18 removed, and with certainparts in cross-section for clearer showing of various interior aspects.As seen in FIG. 2, the transfer device includes a first connector orport 24 for connection to a fluid source such as a syringe, a secondconnector port or mating member 26 for cooperation with the injectiondevice 14 and a fluid flow path 28 connected between them. The firstconnector 24 is shown with the upper syringe receiving portion insection, illustrating a female luer port 30 for receiving the typicalmale luer end of a syringe type fluid source. The first connector has aninternal passageway, not shown, that extends from the luer port 30 tothe flow path 28. The fluid flow path 28 may be of any suitableconstruction such as flexible plastic tubing, a rigid pre-formed flowpath or other. As used herein, the word, “upper,” lower,” “above,”“below” and similar words are only indicative of relative positionalrelationships among various features and are not otherwise intended toimpose limitations of direction.

The second connector 26 is situated in the tray 18 beneath the injectiondevice receiving station or recess 22. The fluid flow path 28 isconnected to an inlet port 32 of the second connector and an internalflow path 34 in the second connector extends from the inlet port 32 toan outlet port 36. Optionally, the internal flow path includes ahydrophobic filter such as hydrophobic membrane 38 covering a connectorvent opening 40 to allow gas bubbles in the medical fluid to vent to theambient atmosphere, while preventing liquid from flowing through thefilter, and another filter such as membrane 42 through which the fluidmust pass to remove particulate or other undesired materials from thefluid. The membrane 48 may have any suitable pore size and may behydrophilic to block the passage of any gas bubbles. A membrane 42having average pore size of about 150-170 microns may be suitable. Inthe illustrated embodiment, the internal flow path 34 extends through arelatively thin and wide cavity or region 44. One side of the cavitycommunicates through the hydrophobic membrane 38 with gas vent opening40 in the connector wall. On the opposite side of the cavity, themembrane 42 extends over the second connector outlet port 36. Therelatively thin height of the cavity promotes contact of any entrainedbubbles with the hydrophobic membrane, while the relatively large cavitywidth provides a large cross section for fluid flow through the cavity.

The second connector 26 includes an upstanding support member 46 to helpsupport the underside of the injection device. The outlet port 36 of thesecond connector also extends upwardly toward the underside of theinjection device. A rigid fluid transfer tube 48 extends from the outletport 36 for insertion into an inlet port of the injection device 14, aswill be described in more detail below. The transfer tube may be made ofany desired material but may preferably be of rigid plastic or metal,such as stainless steel.

The injection device 14, as noted earlier, is described for the mostpart in the PCT publication WO2014/204894 A2 by Enable Injections LLC ofFranklin, Ohio USA, incorporated by reference herein. The injectiondevice is intended for one-time use only, preferably for bolusinjections into a patient while the device is worn by the patient. Theinjection device has a housing 50 that encloses a fluid reservoir,preferably a resilient, expandable reservoir such as an arcuateresilient bladder 52. The injection device housing has a fluid inletport 54 for receiving the fluid transfer tube 48 and a fluid flow path,generally at 56, that extends between the inlet port and the reservoir.In accordance with this description, a one-way flow control valvegenerally at 58 is located in the fluid flow path to control fluid flowbetween the inlet port and the reservoir, allowing medical fluid to flowfrom the inlet port to the reservoir and substantially preventing fluidflow from the reservoir to the inlet port.

As perhaps better seen in FIG. 3, the fluid flow path 56 extends fromthe inlet port 54 into a manifold 60. The illustrated manifold isgenerally v-shaped, with a valve housing 62 at the vertex of thev-shaped manifold, a bladder mounting member 64 on one leg of thev-shaped manifold and a needle housing 66 on the other leg of thev-shaped manifold. The fluid flow path 56 extends into the valve housing62 and branches at the valve housing and extends from the valve housingalong each leg of the v-shaped manifold. This can be better seen inFIGS. 4 and 5 which show the fluid flow path branch 56 a, which extendsthrough the bladder mounting member 64, and the fluid flow path branch56 b, which extends to needle housing 66.

Referring to FIG. 5, the bladder mounting member 64 extends into an openend of an arcuate resilient bladder 52. The open end of the bladder issecured to the mounting member by a circumferential o-ring 68 thatresides in a slot 70 around the mounting member and clamps the bladderwall 71 against the surface of the mounting member. The fluid flow path56 a discharges into the bladder, and FIG. 5 shows the resilient bladderas expanded after filling. When filled, the expanded resilient bladderinherently applies pressure to the fluid contained therein, and providesthe motive force for expelling the fluid through an injection needle 100(FIG. 4) when the injection device is later activated. The flow controlvalve 58 described below allows filling of the bladder under pressurefrom a medical fluid source (e.g. a syringe) and prevents thepressurized fluid in the filled bladder from escaping through the inletport 54.

As better seen in FIGS. 2, 3, and 8, the flow control valve 58 includesa valve body 70 and a valve member 72. A fluid flow lumen 74 extendsthrough the valve body and the valve member is located in the fluid flowlumen. At least one of the valve body and valve member is resilient andrespectively sized such that the valve member 72 is cross-sectionallylarger than the fluid flow lumen 74 when the valve body and valve memberare in a relaxed or unstressed condition. This size relationship resultsin tight annular contact between the valve member and the surface of thevalve body fluid flow lumen, forming what may be referred to as anannular sealing band, zone or localized stress region between the valvebody and valve member, which substantially blocks fluid flow through thefluid flow lumen in the absence of fluid pressure from the inlet port.The resiliency of the valve member and/or valve body allows for movementor resilient flexing of the valve body and/or valve member between anormally closed position in which the valve member and a fluid lumensurface are in contact and blocking flow, and an open position inresponse to fluid pressure from the inlet port in which at least one ofthe valve body and valve member flexes to a spaced apart position thatallows fluid flow between them.

One implementation or version of the valve body can be better seen inenlarged view, for example, in FIGS. 6-9. As shown there, theillustrated valve body includes a base portion 76 and a hollow tubularportion or sleeve 78 extending upwardly from the base portion. Fluidflow lumen 74 extends through the base and the hollow tubular portion orsleeve. The valve body may be made of any suitable material. In theillustrated version, the valve body is resilient and made of elastomericmaterial such as resilient polymer, and more preferably siliconematerial. The material of the valve body may be of selected flexibilityand in one version may have a ShoreA hardness of about 40 or greater.The fluid flow lumen through the base is sized to tightly and sealinglyreceive the fluid transfer tube 48 of the transfer device.

Referring to FIG. 6B, the underside of the base portion 76 optionallyhas a recessed area 80 around the entrance to the lumen 74 for receivingan optional fluid absorbent member 82. The fluid absorbent member mayalso be of any suitable material, size or shape, and in one embodimentis a cellulose disc that is affixed in the recessed area 80 to theunderside of the valve body so that it is adjacent to lumen opening inthe base portion and to the fluid transfer tube. The absorbent memberabsorbs or wicks any small residue of fluid that may escape from thelumen 74 when injection device is removed from the transfer device andthe fluid transfer tube is withdrawn from the valve body.

Although either or both of the valve body 70 and valve member 72 couldbe resilient, in the illustrated embodiment the valve body is resilientand the valve member is rigid. In this embodiment, the valve member isspherically shaped and has a smooth outer surface for sealing contactwith the wall of the fluid flow lumen 74 in the tubular portion orsleeve 78. Stainless steel is one suitable material for the valvemember, and rigid plastic may also be suitable. The relative size of thevalve member and valve housing may be selected to control the tensioninduced in the tubular portion of the valve body when the valve memberis located in the fluid flow lumen 74, which affects the annular sealingpressure exerted by the tubular portion on the valve member, andtherefore the amount of pressure required to open the valve.

One estimation of the pressure required to open the annular seal offluid control valve 58 as described above is provided by the followingformula:

P=4πEt(D−d)/d

where

E=modulus of elasticity for the valve body 70 material

d=inner diameter of the tubular portion or sleeve 78 in the relaxed,unstressed state

D=outer diameter of the spherical valve member 72

t=wall thickness of the tubular portion or sleeve 78

P=the internal pressure to open the valve.

In one particular but non-limiting example, the tubular portion of asilicone valve body, with a Shore A durometer of about 40, has a tubularportion wall thickness of about 0.011 inches (0.2 mm) and an internalfluid flow lumen diameter of about 0.108 inches (2.8 mm) in theunstressed state, with a spherical valve member having an outer diameterof about 0.118 inches (3 mm).

As an alternative to a separate valve member 72, the valve housing 62could include a cavity extension that extends into the open end of thetubular portion 78 of the valve body and is sized (e.g. with a bulbousportion similar in shape to a spherical member) to stretch the tubularportion to provide an annular sealing zone between them, similar infunction to the separate spherical valve member 72. This alternativecould potentially provide cost saving and simplify assembly as compared,for example, to the use of a separate stainless steel valve member.

Turning now to FIGS. 8A and 8B, shown in enlarged detail is the flowcontrol valve 58, valve housing 62, fluid transfer tube 48 and fluidflow path branches 56 a and 56 b. The valve housing defines an internalvalve cavity 84 which, in this embodiment, forms a portion of the fluidflow path 56. The flow control valve is situated within the valvecavity, with the base portion 76 fixed between the valve housing and abottom wall 86 of the injection device housing 50, so that the tubularportion or sleeve of the valve body extends upwardly into the valvecavity. The optional absorbent member 82 is located within lower recess80 in the valve body base, and is situated between the valve body andthe inside surface of bottom wall 86. The absorbent member is thereforespaced from contact with the patient's skin by the thickness of thebottom wall.

FIG. 8A illustrates the flow control valve 58 in the injection device inthe closed position. The valve is generally in this position both beforeand after filling of the resilient bladder 52 with medical fluid, butnot during filling. In this embodiment, as described above, thespherical valve member 72 is larger than the inside diameter of thetubular portion 78 of the valve body 70. The tension induced in theresilient sleeve causes the lumen 74 surface in the tubular portion toseal against the annular surface of the valve member as described above.

FIG. 8A also shows an additional and optional aspect of the presentsubject matter. An optional additional or supplemental seal may beprovided in the flow control valve 58 to better assure that medicalfluid does not leak from the reservoir to the inlet port 54 afterfilling. More specifically, the valve body 70 may have an additionalinternal annular valve seat that engages the valve member in the closedposition. One example of such a seat is illustrated in FIG. 8A in theform of an annular radial shoulder 88 located between the base portion76 and tubular portion 78. In this embodiment the spherical valve memberalso contacts the internal shoulder 88 in the valve closed position,providing additional resistance to leakage from the reservoir.

As visible in the figures, in this implementation of the flow controlvalve, the valve cavity 84 is larger than the tubular portion 78 of thevalve body 70 so that fluid in the flow path 56 can flow around at leastpart of the outer surface of the valve body. This allows medical fluidto flow from the reservoir through branch 56 a, through the valve cavity84 and into branch 56 b to the injection needle. This also contributesto a seal between the valve member and valve body, as will be describedin more detail below with respect to FIG. 9.

FIG. 8B is an illustration of the flow control valve 58 during filing ofthe reservoir. Medical fluid flows under pressure from a fluid source,such as a syringe, into the fluid transfer tube 48 and into fluid flowlumen 74 in the valve body 70. The pressure of the fluid lifts the valvemember 72 away from annular shoulder 88 (if optionally employed) andcauses the resilient tubular portion 78 to flex radially outwardly andprovide a space between the valve member and surface of fluid flow lumen74, allowing fluid to flow from the fluid transfer tube through branch56 a and into the reservoir. It should be noted that before theinjection device is activated, the injection needle lumen is not open tothe flow path branch 56 b and thus fluid flowing into the injectiondevice largely flows into the reservoir. The valve cavity is dimensionedor toleranced such that the valve member 72 cannot be pushed out of theopen end of tubular portion 78 of the valve body 70 by the incomingfluid. When the filling is complete and the pressure from the fluidsource (e.g., syringe) is less than the opening pressure for the valve,the valve automatically and inherently returns to the closed position.Although the pressure of the filled reservoir is enough to force medicalfluid through an injection needle when the injection device iseventually actuated, it is not large enough to open the valve. Themedical fluid is retained in the reservoir until the injection device isneeded, and the flow control valve prevents leakage to the inlet port54.

When the injection device 14 is removed from the transfer device 12, thefluid transfer tube 48 is withdrawn from the base of the valve body 70.A very small amount of fluid may be present below the valve member and,if so, this fluid will be absorbed by the absorbent member 82, which isadjacent to the fluid inlet port 54 and spaced by the thickness of thebottom wall 86 of the injection device housing 50 from direct contactwith the patient's skin.

FIG. 9 diagrammatically illustrates the forces acting on the flowcontrol valve 58 after the injection device has been filled and beforeit has been actuated for injection into a patient. At this point in itsuse, the expanded resilient reservoir exerts an expulsion pressure Pe onthe medical fluid in the reservoir and in fluid flow path 56, whichincludes the valve cavity 44. Because the medical fluid source is nolonger exerting any fill pressure, the pressure at the fluid inlet portmay be assumed to be at atmospheric pressure. The valve cavity beinglarger than the tubular portion of the valve body, medical fluidpressure Pe is exerted against the outer surface of the tubular portionand against the exposed upper surface of the valve member 72 as shown.The pressure against the outside of the resilient tubular portion 78adds to the inherent resilient force of the tubular portion in forcingthe surface of lumen 74 against the surface of the valve member 72,enhancing the seal therebetween. Also, for valves having the optionalsecondary seal of the valve member against internal valve seat, such asshoulder 88 of the valve body, the fluid pressure Pe exerted against theexposed surface of the valve member helps to force the valve memberagainst the valve seat to enhance the secondary seal therebetween.

When the injection device is activated and the injection needle isdeployed into the patient's skin, the inlet port of the injection needleis open to flow path branch 56 b, and reservoir pressure Pe expels fluidfrom the reservoir through the needle and, into the patient.

Additional Aspects

Without limiting or detracting from the foregoing description,additional features, embodiments or aspects of the present subjectmatter include:

Aspect 1. A fluid flow control valve including: a valve housing defininga valve cavity having an inlet and outlet, a valve body disposed in thevalve cavity between the inlet and outlet and having a fluid flow lumen,a valve member located within the fluid flow lumen of the valve body,the valve body being resilient, and the valve body and valve memberbeing respectively sized such that the valve member is cross-sectionallylarger than the fluid flow lumen when the valve body in a unstressedcondition so as to provide annular contact between the valve member andvalve body, the annular contact substantially blocking fluid flowthrough the fluid flow lumen in the absence of fluid pressure from theinlet, the resiliency of the resilient valve body allowing for flexingbetween a normally closed position in which the valve member and a fluidlumen surface are in contact and blocking flow, and an open position inresponse to fluid pressure from the inlet in which at least one of thevalve body and valve member flexes to a spaced apart position thatallows fluid flow between them, and the valve body including an exteriorsurface exposed at least in part to pressure from fluid downstream ofthe valve body so as to encourage sealing contact between the valve bodyand valve member.

Aspect 2. The fluid flow control valve of aspect 1 in which valve bodyincludes a base portion carried by the housing and hollow sleeveextending from the base portion, the interior of the sleeve defining thefluid flow lumen, a fluid orifice in the base portion communicating withone end of the sleeve and the fluid inlet port, the other end of thesleeve being open and communicating with the outlet, the valve memberbeing disposed in the sleeve.

Aspect 3. The fluid flow control valve of aspect 1 or 2 furthercomprising a fluid absorbent member adjacent to the valve cavity inlet.

Aspect 4. The fluid flow control valve of any one of aspects 1-3 inwhich the valve body includes an annular valve seat in the fluid flowlumen between the valve member and inlet for engagement by the valvemember to provide an additional seal against fluid flow through thelumen.

Aspect 5. The fluid flow control valve of aspect 4 in which the annularvalve seat comprises a radial shoulder.

Aspect 6. The fluid flow control valve of any one of aspects 1-5 inwhich the valve body is made of silicone.

Aspect 7. The fluid flow control valve of any one of aspects 2-6 inwhich the valve member is generally spherically shaped and the fluidflow lumen in the sleeve is generally cylindrically shaped.

Aspect 8. The fluid flow control valve of any one of aspects 1-7 inwhich the sleeve is made of elastomeric material having a Shore HardnessA of about 40 or greater.

Aspect 9. A medical fluid injection or transfer device comprising: ahousing; a reservoir within the housing for receiving medical fluid; aninlet port in the housing for receiving medical fluid from a source; afluid flow path in the housing communicating between the inlet port andreservoir; the fluid flow path including a one-way valve, the one-wayvalve including: a valve body including a fluid flow lumen therethrough;a valve member located within the fluid flow lumen; and at least one ofthe valve body and valve member being resilient and respectively sizedfor movement between a normally closed position in which the valvemember and a fluid lumen surface are in sufficient annular contact toblock fluid flow through the fluid flow lumen in the absence of fluidpressure from the inlet port, and an open position in response to fluidpressure from the inlet port in which at least one of the valve body andvalve member flexes to a spaced apart position that allows fluid flowbetween them.

Aspect 10. The injection or transfer device of aspect 9 in which thevalve body is resilient.

Aspect 11. The injection or transfer device of aspect 9 or 10 in whichthe valve member is resilient.

Aspect 12. The injection or transfer device of any one of aspects 9-11in which the reservoir comprises an expandable resilient balloon.

Aspect 13. The injection or transfer device of any one of aspects 9-12in which valve body includes a base portion carried by the housing andhollow sleeve extending from the base portion, the interior of thesleeve defining the fluid flow lumen, a fluid orifice in the baseportion communicating with one end of the sleeve and the fluid inletport, the other end of the sleeve being open and communicating with thereservoir, the valve member being disposed in the sleeve.

Aspect 14. The injection or transfer device of any one of aspects 9-13further comprising a fluid absorbent member adjacent to the orifice.

Aspect 15. The injection or transfer device of any one of aspects 9-14wherein the sleeve is has an outer surface in fluid communication withthe reservoir.

Aspect 16. The injection or transfer device of any one of aspects 9-15further comprising a fluid flow manifold defining a valve body cavitycontaining the valve body and the valve member is defined by a portionof the manifold that extends into the fluid flow lumen.

Aspect 17. The injection or transfer device of any one of aspects 9-16in which the valve body includes an annular valve seat in the fluid flowlumen between the valve member and inlet port for engagement by thevalve member to provide a secondary seal against fluid flow from thereservoir toward the inlet port.

Aspect 18. The injection or transfer device of any one of aspects 9-17in which the valve member and valve lumen are sized such that in anunbiased condition the valve member has a larger cross-section size thanthe valve lumen and resilient contact between the valve member and valvelumen normally prevents fluid flow through the valve lumen.

Aspect 19. A medical fluid injection device comprising: an injectiondevice housing; a resilient expandable reservoir within the housing forreceiving medical fluid; an injection needle carried by the housing; aninjection flow path for communication between the injection needle andreservoir; an port in the housing for receiving medical fluid underpressure from a source; an inlet fluid flow path in the housingcommunicating between the inlet port and reservoir for introducingmedical fluid into the reservoir; the inlet fluid flow path including aone-way valve for allowing fluid flow from the inlet port into thereservoir and preventing fluid flow from the reservoir to the inletport, the one-way valve including: a valve body including asubstantially resilient sleeve portion through which inlet flow pathextends, a valve inlet for fluid flow into one end of the inlet flowpath and a valve outlet for fluid flow from the other end of the inletflow path; a substantially rigid valve member located within the inletflow path of the resilient sleeve portion between the valve inlet andvalve outlet; and the valve member being sized such that it has across-sectional size larger than the inlet flow path in the unbiasedcondition such that the sleeve normally contacts the valve member andblocks fluid flow through the valve body from the reservoir to the inletport, the sleeve being resiliently expandable under fluid pressure fromthe inlet port to allow fluid flow between the valve body and valvemember.

Aspect 20. The injection device of aspect 19 in which the valve body islocated in the inlet fluid flow path so as to allow fluid pressure fromthe reservoir to be exerted against an outer surface of the sleeveportion.

Aspect 21. The injection device of aspect 19 or 20 in which the valvebody includes an internal valve seat which the valve member contactswhen in the flow blocking condition, providing an additional sealagainst fluid flow through the reservoir toward the inlet port.

Aspect 22. The injection device of anyone of aspects 19-21 in whichvalve body includes a base portion carried by the housing and includinga fluid inlet communicating with the fluid flow path.

Aspect 23. The injection device of any one of aspects 19-22 furthercomprising a fill member extending through the fluid inlet.

Aspect 24. The injection device of any one of aspect 23 furthercomprising a fluid absorbent member adjacent to the inlet to absorbliquid from the inlet upon withdrawal of the fill member.

Aspect 25. The injection device of any one of aspects 19-24 in which thevalve member is generally spherically shaped and the fluid flow path inthe sleeve is generally cylindrically shaped.

Aspect 26. The injection device of any one aspects 19-25 in which thesleeve is made of elastomeric material having a Shore Hardness A ofabout 40 or greater.

Aspect 27. The injection device of any one of aspects 19-26 furthercomprising a fluid flow manifold defining a valve body cavity receivingthe valve body and the valve member is defined by a portion of themanifold that extends into sleeve.

Aspect 28. A medical fluid flow control device comprising: a housing; aresilient expandable reservoir within the housing; an inlet port in thehousing for receiving medical fluid from a source and an outlet port inthe housing for flow of fluid from the housing and a fluid flow pathbetween the inlet port and the reservoir and between the reservoir andthe outlet port; the fluid flow path between the inlet port andreservoir including a normally closed one-way valve for allowing fluidflow from the inlet port into the reservoir and preventing fluid flowfrom the reservoir to the inlet port, the one-way valve including avalve body, the valve body including a resilient hollow sleeve portiondefining a fluid flow lumen therein, a valve body inlet for fluid flowinto one end of the fluid flow lumen from the inlet port and a valvebody outlet for fluid flow from the other end of the fluid flow lumeninto the reservoir; a substantially separate rigid valve member locatedwithin the lumen of the resilient sleeve portion; the valve member beingsized such that the valve member is larger than the lumen of theresilient sleeve when the sleeve is in an unbiased condition, such thatthe sleeve portion normally exerts an annular inward force against anouter surface of the valve member to provide an annular first sealbetween the valve member and sleeve and block flow through the fluidflow lumen from the reservoir to the inlet port, the sleeve beingresiliently expandable under fluid pressure from the inlet port to allowfluid flow between the valve body and valve member and into theresilient reservoir, the sleeve having an outer surface in fluidcommunication with the fluid flow path between the valve and reservoir;and the valve body further defining an annular valve seat in the lumenbetween the valve member and valve body inlet, which valve seat iscontacted by the valve member in the normally closed condition toprovide an additional seal against fluid flow from the reservoir, thevalve member being movable away from the valve seat under fluid pressurefrom the inlet port to allow fluid flow through the fluid flow lumenbetween the valve seat and valve member.

Aspect 29. A method of controlling fluid flow employing a flow controlvalve comprising a resilient valve body including a fluid flow lumentherein and a rigid valve member located within the fluid flow lumen,the rigid valve member being sized larger than the valve lumen tocontact the surface of the valve lumen and block flow therethrough whenthe valve body is in a relaxed condition, the method including: applyingsufficient upstream fluid pressure in the fluid flow lumen to flex theresilient valve body to a position in which the surface of the fluidflow lumen is spaced from the valve member to allow fluid flow throughthe lumen; reducing the upstream pressure to allow the resilient valvebody to contact the valve member; and contacting an exterior surface ofthe resilient valve body with downstream fluid under pressure, to assistin providing sealing contact between the surface of the fluid flow lumenand the valve member.

Aspect 30. The method of aspect 29 in which the flow control valve islocated in a flow path communicating with a resilient expandabledownstream reservoir, and the step of applying upstream fluid pressureincludes flowing fluid through the lumen and into the downstreamreservoir, the upstream fluid pressure being sufficient to expand thereservoir, the reservoir being biased by its resiliency to expel fluidunder pressure.

Aspect 31. The method of aspect 29 or 30 employing the flow controlvalve of any one of aspects 1-8.

While the flow control valve herein is described by reference tospecifically illustrated structures shown in the accompanying figures,it is understood that the present subject matter is not limited to suchspecific structures and has application in other forms and deviceswithout departing from the scope of this disclosure. For this reason,reference is required to the following claims to ascertain the scope ofthe present subject matter.

1. A fluid flow control valve including: a valve housing defining avalve cavity having an inlet and outlet, a valve body disposed in thevalve cavity between the inlet and outlet and having a fluid flow lumen,a valve member located within the fluid flow lumen of the valve body,the valve body being resilient, and the valve body and valve memberbeing respectively sized such that the valve member is cross-sectionallylarger than the fluid flow lumen when the valve body in a unstressedcondition so as to provide annular contact between the valve member andvalve body, the annular contact substantially blocking fluid flowthrough the fluid flow lumen in the absence of fluid pressure from theinlet, the resiliency of the resilient valve body allowing for flexingbetween a normally closed position in which the valve member and a fluidlumen surface are in contact and blocking flow, and an open position inresponse to fluid pressure from the inlet in which at least one of thevalve body and valve member flexes to a spaced apart position thatallows fluid flow between them, and the valve body including an exteriorsurface exposed at least in part to pressure from fluid downstream ofthe valve body so as to encourage sealing contact between the valve bodyand valve member.
 2. The fluid flow control valve of claim 1 in whichvalve body includes a base portion carried by the housing and hollowsleeve extending from the base portion, the interior of the sleevedefining the fluid flow lumen, a fluid orifice in the base portioncommunicating with one end of the sleeve and the fluid inlet port, theother end of the sleeve being open and communicating with the outlet,the valve member being disposed in the sleeve.
 3. The fluid flow controlvalve of claim 1 further comprising a fluid absorbent member adjacent tothe valve cavity inlet.
 4. The fluid flow control valve of claim 1 inwhich the valve body includes an annular valve seat in the fluid flowlumen between the valve member and inlet for engagement by the valvemember to provide an additional seal against fluid flow through thelumen.
 5. The fluid flow control valve of claim 4 in which the annularvalve seat comprises a radial shoulder.
 6. The fluid flow control valveof claim 1 in which the valve body is made of silicone.
 7. The fluidflow control valve of claim 2 in which the valve member is generallyspherically shaped and the fluid flow lumen in the sleeve is generallycylindrically shaped.
 8. The fluid flow control valve of claim 1 inwhich the sleeve is made of elastomeric material having a Shore HardnessA of about 40 or greater. 9.-14. (canceled)
 15. A medical fluidinjection or transfer device comprising: a housing; a reservoir withinthe housing for receiving medical fluid; an inlet port in the housingfor receiving medical fluid from a source; a fluid flow path in thehousing communicating between the inlet port and reservoir; the fluidflow path including a one-way valve, the one-way valve including: avalve body including a fluid flow lumen therethrough; a valve memberlocated within the fluid flow lumen; at least one of the valve body andvalve member being resilient and respectively sized for movement betweena normally closed position in which the valve member and a fluid lumensurface are in sufficient annular contact to block fluid flow throughthe fluid flow lumen in the absence of fluid pressure from the inletport, and an open position in response to fluid pressure from the inletport in which at least one of the valve body and valve member flexes toa spaced apart position that allows fluid flow between them; said valvebody including a base portion carried by the housing and a hollow sleeveextending from the base portion, the interior of the sleeve defining thefluid flow lumen, a fluid orifice in the base portion communicating withone end of the sleeve and the fluid inlet port, the other end of thesleeve being open and communicating with the reservoir, the valve memberbeing disposed in the sleeve; wherein the sleeve is has an outer surfacein fluid communication with the reservoir.
 16. A medical fluid injectionor transfer device comprising: a housing; a reservoir within the housingfor receiving medical fluid; an inlet port in the housing for receivingmedical fluid from a source; a fluid flow path in the housingcommunicating between the inlet port and reservoir; the fluid flow pathincluding a one-way valve, the one-way valve including: a valve bodyincluding a fluid flow lumen therethrough; a valve member located withinthe fluid flow lumen; at least one of the valve body and valve memberbeing resilient and respectively sized for movement between a normallyclosed position in which the valve member and a fluid lumen surface arein sufficient annular contact to block fluid flow through the fluid flowlumen in the absence of fluid pressure from the inlet port, and an openposition in response to fluid pressure from the inlet port in which atleast one of the valve body and valve member flexes to a spaced apartposition that allows fluid flow between them; and a fluid flow manifolddefining a valve body cavity containing the valve body and the valvemember is defined by a portion of the manifold that extends into thefluid flow lumen. 17.-19. (canceled)
 20. A medical fluid injectiondevice comprising: an injection device housing; a resilient expandablereservoir within the housing for receiving medical fluid; an injectionneedle carried by the housing; an injection flow path for communicationbetween the injection needle and reservoir; a port in the housing forreceiving medical fluid under pressure from a source; an inlet fluidflow path in the housing communicating between the inlet port andreservoir for introducing medical fluid into the reservoir; the inletfluid flow path including a one-way valve for allowing fluid flow fromthe inlet port into the reservoir and preventing fluid flow from thereservoir to the inlet port, the one-way valve including: a valve bodyincluding a substantially resilient sleeve portion through which inletflow path extends, a valve inlet for fluid flow into one end of theinlet flow path and a valve outlet for fluid flow from the other end ofthe inlet flow path; a substantially rigid valve member located withinthe inlet flow path of the resilient sleeve portion between the valveinlet and valve outlet; and the valve member being sized such that ithas a cross-sectional size larger than the inlet flow path in theunbiased condition such that the sleeve normally contacts the valvemember and blocks fluid flow through the valve body from the reservoirto the inlet port, the sleeve being resiliently expandable under fluidpressure from the inlet port to allow fluid flow between the valve bodyand valve member; wherein the valve body is located in the inlet fluidflow path so as to allow fluid pressure from the reservoir to be exertedagainst an outer surface of the sleeve portion. 21.-26. (canceled)
 27. Amedical fluid injection device comprising: an injection device housing;a resilient expandable reservoir within the housing for receivingmedical fluid; an injection needle carried by the housing; an injectionflow path for communication between the injection needle and reservoir;an port in the housing for receiving medical fluid under pressure from asource; an inlet fluid flow path in the housing communicating betweenthe inlet port and reservoir for introducing medical fluid into thereservoir; the inlet fluid flow path including a one-way valve forallowing fluid flow from the inlet port into the reservoir andpreventing fluid flow from the reservoir to the inlet port, the one-wayvalve including: a valve body including a substantially resilient sleeveportion through which inlet flow path extends, a valve inlet for fluidflow into one end of the inlet flow path and a valve outlet for fluidflow from the other end of the inlet flow path; a substantially rigidvalve member located within the inlet flow path of the resilient sleeveportion between the valve inlet and valve outlet; and the valve memberbeing sized such that it has a cross-sectional size larger than theinlet flow path in the unbiased condition such that the sleeve normallycontacts the valve member and blocks fluid flow through the valve bodyfrom the reservoir to the inlet port, the sleeve being resilientlyexpandable under fluid pressure from the inlet port to allow fluid flowbetween the valve body and valve member; and a fluid flow manifolddefining a valve body cavity receiving the valve body and the valvemember is defined by a portion of the manifold that extends into thesleeve.
 28. A medical fluid flow control device comprising: a housing; aresilient expandable reservoir within the housing; an inlet port in thehousing for receiving medical fluid from a source and an outlet port inthe housing for flow of fluid from the housing and a fluid flow pathbetween the inlet port and the reservoir and between the reservoir andthe outlet port; the fluid flow path between the inlet port andreservoir including a normally closed one-way valve for allowing fluidflow from the inlet port into the reservoir and preventing fluid flowfrom the reservoir to the inlet port, the one-way valve including avalve body, the valve body including a resilient hollow sleeve portiondefining a fluid flow lumen therein, a valve body inlet for fluid flowinto one end of the fluid flow lumen from the inlet port and a valvebody outlet for fluid flow from the other end of the fluid flow lumeninto the reservoir; a substantially separate rigid valve member locatedwithin the lumen of the resilient sleeve portion; the valve member beingsized such that the valve member is larger than the lumen of theresilient sleeve when the sleeve is in an unbiased condition, such thatthe sleeve portion normally exerts an annular inward force against anouter surface of the valve member to provide an annular first sealbetween the valve member and sleeve and block flow through the fluidflow lumen from the reservoir to the inlet port, the sleeve beingresiliently expandable under fluid pressure from the inlet port to allowfluid flow between the valve body and valve member and into theresilient reservoir, the sleeve having an outer surface in fluidcommunication with the fluid flow path between the valve and reservoir;and the valve body further defining an annular valve seat in the lumenbetween the valve member and valve body inlet, which valve seat iscontacted by the valve member in the normally closed condition toprovide an additional seal against fluid flow from the reservoir, thevalve member being movable away from the valve seat under fluid pressurefrom the inlet port to allow fluid flow through the fluid flow lumenbetween the valve seat and valve member.
 29. A method of controllingfluid flow employing a flow control valve comprising a resilient valvebody including a fluid flow lumen therein and a rigid valve memberlocated within the fluid flow lumen, the rigid valve member being sizedlarger than the valve lumen to contact the surface of the valve lumenand block flow therethrough when the valve body is in a relaxedcondition, the method including: applying sufficient upstream pressurein the fluid flow lumen to flex the resilient valve body to a positionin which the surface of the fluid flow lumen is spaced from the valvemember to allow fluid flow through the lumen; reducing the upstreampressure to allow the resilient valve body to contact the valve member;and contacting an exterior surface of the resilient valve body withdownstream fluid under pressure, to assist in providing sealing contactbetween the surface of the fluid flow lumen and the valve member. 30.The method of claim 29 employing the flow control valve of claim 1.